Home / 510(k) Clearances / K910875

510(k) K910875

ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE by ETHICON, Inc. — Product Code FDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
March 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Pneumoperitoneum, Automatic
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

Other clearances by ETHICON, Inc.

  • K252047 — STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (May 18, 2026)
  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K243897 — PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Su (November 12, 2025)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212380 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Sutu (February 22, 2022)
  • K213512 — DERMABOND PRINEO Skin Closure System (December 7, 2021)
  • K201996 — Monocryl Plus Antibacterial Suture (December 21, 2020)
  • K201686 — GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ (September 17, 2020)